Inspections, Compliance, Enforcement, and Criminal Investigations

Page 11

GUIDE TO INSPECTIONS OF ELECTROMAGNETICCOMPATIBILITY ASPECTS OF MEDICAL DEVICEQUALITY SYSTEMS

Implementing and Recording Changes

The changes which are implemented and recorded should be identical to the solution which was implemented for verification or validation. For example, no last-minute labeling changes should be made after validation. Any labeling changes should be validated and then fully implemented. The firm will have to decide whether the change should be implemented to existing units as well as new inventory. See the Recall and Upgrade section of this document for further guidance.

Disseminating Information

A change to the device is most likely to be initiated by an engineering department. Other departments such as manufacturing, purchasing, production, quality assurance, regulatory affairs, etc. should be informed, since each will have its own responsibilities in effecting an EMC change.

RECALLS AND UPGRADES

As manufacturers begin to test their devices to meet voluntary EMC standards, device modifications or labeling changes resulting from such testing generally will be considered upgrades. CDRH will not consider modifications of marketed devices to reduce EMI to be recalls unless there is a significant hazard or violation of the Federal Food, Drug, and Cosmetic Act (the Act). In certain cases, the Center or the firm might choose to issue a safety alert. As a result of a firm's analysis or an evaluation by CDRH, the firm may consider several options: issue warnings and guidance to the users, revise device labeling, modify the device, or conduct market withdrawals or recalls. If a labeling change or modification results in a new intended use, a new 510(k) may need to be submitted to CDRH. In the conduct of an upgrade or recall, the firm may choose to issue a letter to users, amend user guidance/operator instructions, and/or revise other labeling to provide warnings and recommendations for unusual or changing use environments. The Agency may determine that this additional user guidance adequately addresses the potential hazard and not require a recall. The determination whether a modification would constitute a recall or be considered an upgrade would be based on the hazard associated with the device's deficiency or whether the Act was violated. If CDRH or the manufacturer identifies that there exists a potential hazard in accordance with section 518 of the Act, then CDRH will classify it as a recall and require notification to purchasers following normal procedures as outlined in 21 CFR 7.40 - 7.59, the Investigations Operations Manual (IOM), Chapter 8, and the Regulatory Procedures Manual (RPM), Chapter 7. The Agency has authority under section 518 to require notification and recall if there is a reasonable probability that a device would cause serious, adverse health consequences or death. Appendix C may be helpful in determining the level of risk associated with EMI-related modifications to a device.

The following are examples of various situations:

Upgrade: wheelchairs

When CDRH testing determined that certain powered wheelchairs and powered scooters were susceptible to EMD, manufacturers worked with CDRH to investigate the problems. CDRH scientists developed improved test methods. In addition, one wheelchair manufacturer worked in cooperation with CDRH to make appropriate shielding and circuitry modifications, resulting in greatly improved immunity. Although CDRH determined that there was not enough evidence to warrant a recall, CDRH notified manufacturers that future premarket submissions on powered wheelchairs and scooters should address EMC in labeling and testing. The modifications and revised labeling are considered upgrades.